FDA 510(k)

Sistema de Ablação a Vapor de RF Médico Aqua

Número K: K241271 · 2024-12-12

Data da decisão2024-12-12

Código do produtoKNS

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Aqua Medical RF Vapor Ablation System is the device name listed in this FDA 510(k) record. The listed applicant is Aqua Medical, Inc.. It received FDA 510(k) clearance on 2024-12-12 under 510(k) number K241271. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Aqua Medical RF Vapor Ablation System?

Aqua Medical RF Vapor Ablation System is a medical device that received FDA 510(k) clearance on 2024-12-12. The listed applicant is Aqua Medical, Inc.. The 510(k) number is K241271.

When did Aqua Medical RF Vapor Ablation System receive FDA 510(k) clearance?

Aqua Medical RF Vapor Ablation System received FDA 510(k) clearance on 2024-12-12, under 510(k) number K241271.

Who is the listed applicant for Aqua Medical RF Vapor Ablation System?

The FDA 510(k) record lists Aqua Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aqua Medical RF Vapor Ablation System?

The FDA product code for Aqua Medical RF Vapor Ablation System is KNS.

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Outros registros que listam Aqua Medical, Inc. como candidato(a)

K251226Sistema de Ablação a Vapor de RF Médico Aqua K213627RF Vapor System K211282Sistema de Vapor de RF Médico Aqua K183595Sistema de Vapor de RF Médico Aqua

Dispositivos Relacionados (Código: KNS)

K262460Rezum SystemBoston Scientific K260962SphincterotomeTaewoong Medical Co., Ltd.K252388Vanquish Water Vapor Ablation DeviceFrancis Medical, Inc.K252889Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)Olympus Medical Systems Corporation K250945Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)Olympus Medical Systems Corp.K250351Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)Olympus Medical Systems Corporation

Fonte oficial

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